Does sham point location matter 2

Stimulated by Lee et al 2023.[1]

SR – systematic review
NMA – network meta-analysis
KIOM – Korean Institute of Oriental Medicine
SATS – sham acupuncture therapy sham point
SATV – sham acupuncture therapy verum point
IPDM – individual patient data meta-analysis
EBM – evidence based medicine
SMD – standardised mean difference
CI – confidence interval

key to acronyms

I guess it was inevitable that there would be more SRs with NMA examining the differences between sham point location following on from the first one I highlighted here: Does sham point location matter.

The first focussed on chronic low back pain,[2] but this NMA looks at cancer pain. It comes from the same group at KIOM, with the same first author Boram Lee.

As I mentioned in the previous blog on this topic (see link above), I have significant doubts that there is any physiological difference between ‘so called’ verum points and sham points. Perhaps the most important difference is in the mind and intention of the practitioners and researchers resulting from their training.

I would argue that we should not ask any research question in the field of acupuncture unless we have a physiological basis to justify that question – often a difference between two interventions. In this case, NMA methodology is used to examine the difference in the effects measured between verum acupuncture and 2 different locations of sham acupuncture (SATS and SATV). The first 2 NMAs from the same group in this area compared the effects of real acupuncture in sham controlled trials using non-penetrating sham devices with real acupuncture in sham controlled trials using penetrating sham.[3,4]

We already knew from the Vickers IPDM that the difference between acupuncture and sham was larger in trials using non-penetrating sham acupuncture,[5] but I was concerned about the rigorous (explanatory) EBM approach that only considered group mean differences and took no account of intra group differences from baseline (a more pragmatic perspective). This latter effect is essentially what we see in practice – the total effect of an intervention including specific and non-specific effects. I was also starting to worry about how the use of sham devices in the real acupuncture group restricted the ability of the acupuncture practitioner to perform the best verum acupuncture (see Trust me…).

So, I was pleased to see the first of these NMAs from KIOM demonstrate a dramatic difference between verum acupuncture with and without use of a sham device in menopausal hot flushes (see Do sham devise impede real acupuncture?). The difference was not as dramatic but still apparent when OA knee was the topic of the second such NMA (see Sham devices impede real acupuncture 2023).

Now the team’s focus has changed to point location in the sham group and we have lost any physiological justification for the research question, so we are subject to the potential of statistics to demonstrate differences by chance (type I statistical error) and wide distribution parameters (type II statistical error).

In the first of these NMAs on chronic low back pain,[2] I suspected that the result was related to inclusion of bothersomeness rather than pain intensity in an isolated node of the NMA (the node for SATV). In the second, highlighted here, we have a tiny sample (n=33) on another isolated node for SATV.

This NMA included 7 studies with 527 patients – one trial included in the SR could not be included in the NMA due to insufficient data reporting. Most of the data in this network was in the nodes for verum acupuncture (n=247) and SATS (n=196), with data from just 33 patients in the SATV node. The only significant result from the NMA was the comparison with the most data – verum acupuncture vs SATS (SMD: 0.75, CI: 0.14 to 1.36). There was a trend in favour of verum acupuncture over SATV (SMD: 0.39, CI: -0.58 to 1.36), but the CI was almost double that for the comparison with SATS, so it was not significant. Equally, there was no significant difference between SATV and SATS.

But it is not all about location in this SR and NMA… there was a mixture of body acupuncture and ear acupuncture included. Interestingly, the SATV studies only included acupuncture with a maximum depth of needle insertion of 1.5mm, whereas 2 of the 5 SATS studies included deep insertion at body points. Whether or not this made a difference is impossible to say, but it demonstrates that there were more differences involved than are is apparent from reading the title of the paper.

In conclusion, I remain to be convinced that point location is the most relevant aspect in any difference between SATV and SATS that is measured in NMAs of clinical trials of acupuncture. I think it would be preferable to examine differences in sensory stimulation modes rather than precise intra-segmental location.

References

1          Lee B, Kwon C-Y, Lee HW, et al. Different Outcomes According to Needling Point Location Used in Sham Acupuncture for Cancer-Related Pain: A Systematic Review and Network Meta-Analysis. Cancers. 2023;15:5875.

2          Lee B, Kwon C-Y, Lee HW, et al. Needling Point Location Used in Sham Acupuncture for Chronic Nonspecific Low Back Pain: A Systematic Review and Network Meta-Analysis. JAMA Netw Open. 2023;6:e2332452.

3          Kim T-H, Lee MS, Alraek T, et al. Acupuncture in sham device controlled trials may not be as effective as acupuncture in the real world: a preliminary network meta-analysis of studies of acupuncture for hot flashes in menopausal women. Acupunct Med. 2020;38:37–44.

4          Lee B, Kim T-H, Birch S, et al. Comparative effectiveness of acupuncture in sham-controlled trials for knee osteoarthritis: A systematic review and network meta-analysis. Front Med. 2022;9:1061878.

5          Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018;19:455–74.


Declaration of interests MC